Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Testosterone Topical Gel, 1.62% Metered Pump
Testosterone, 1.62% Metered Pump · 1 trial · 2 indications
Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration.
Area under the concentration vs. time curve, from time of first dosing to infinity
Maximum reported concentration. Estimated for both baseline
| Arm | Type | Description |
|---|---|---|
| AndroGel | ACTIVE_COMPARATOR | AndroGel (testosterone gel) 1.62% Metered-Dose Pump. One actuation 20.25 mg |
| Testosterone Gel | EXPERIMENTAL | Testosterone Topical Gel, 1.62% Metered Pump. One actuation of 20.25 mg. |
| Name | Type | Description |
|---|---|---|
| Testosterone Topical Gel, 1.62% Metered Pump | DRUG | - |
| AndroGel (testosterone gel) 1.62% Metered-Dose Pump | DRUG | - |
Inclusion Criteria: * Healthy adult men with hypogonadism with testosterone levels \<250ng/dL * 18 to 65 years of age (inclusive) * Have normal PSA \< 4.0ng/mL * Weighing a minimum of 50 kg and having a body mass index between 18.0 and 38.0 kg/m2. * Good health as determined by medical history and ...
Testosterone, 1.62% Metered Pump is a topical gel formulation of testosterone used for testosterone replacement in adult males with primary hypogonadism. It is also studied in hypogonadotropic hypogonadism. The metered pump delivers a measured dose of the gel through the skin to restore testosterone levels in deficient men.
Testosterone, 1.62% Metered Pump targets the androgen receptor (AR), where it acts as an agonist. By binding and activating the androgen receptor, testosterone replaces endogenous hormone and supports androgen-dependent physiological functions in men with primary hypogonadism. The target class is agonist at the AR.
Testosterone, 1.62% Metered Pump is developed by Amneal Pharmaceuticals, Inc., which trades under the ticker AMRX. The company is the sponsor of the clinical program for this topical testosterone gel product.
Testosterone, 1.62% Metered Pump is in Phase 3 development. It is an investigational product and is not approved. The Phase 3 program includes a completed bioequivalence study in testosterone deficient adult males, evaluating the test and reference topical gel formulations.
Testosterone, 1.62% Metered Pump has been evaluated in one completed Phase 3 trial, NCT02110368. This was a bioequivalence study of the test and reference testosterone topical gel, 1.62% metered pump, in testosterone deficient adult male subjects under fasting conditions. The study enrolled 32 participants in the United States.
Yes, Testosterone, 1.62% Metered Pump is also known as Testosterone Topical Gel, 1.62% Metered Pump. Both names refer to the same product developed by Amneal Pharmaceuticals, Inc. for primary hypogonadism.